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International Angiology 2001 December;20(4):288-94


lingua: Inglese

Naftidrofuryl in quality of life (NIQOL). A Belgian Study

D’Hooge D., Lehert P. *, Clement D. L. **

On behalf of the investigators of the NIQOL study: MERCK nv/sa, Overijse, Belgium * Département d’Analyses Statistiques, Université de Mons, Mons, Belgium ** University Hospital, Gent, Belgium


Back­ground. Using a dis­ease spe­cif­ic ques­tion­naire, the Claud­i­ca­tion Scale (CLAU-S), we under­took a dou­ble blind, pla­ce­bo con­trolled study in ­patients with inter­mit­tent claud­i­ca­tion (IC) to deter­mine wheth­er the ­increase in the pain-free walk­ing dis­tance, pre­vi­ous­ly dem­on­strat­ed with naf­ti­drof­u­ryl, is reflect­ed as an improve­ment in the ­patients’ qual­ity of life.
Meth­ods. Fol­low­ing an ­initial one month pla­ce­bo run-in 235 ­patients, with ­stable IC for at least 3 ­months, were ran­dom­ized to ­either naf­ti­drof­u­ryl (Prax­i­lene®), at a dos­age of 200 mg three times daily, or match­ing pla­ce­bo, for 6 ­months. All ­patients com­plet­ed the self-admin­is­tered CLAU-S ques­tion­naire which is divid­ed into 6 dimen­sions, ­before the start of treat­ment, at 3 and at 6 ­months. Sta­tis­ti­cal anal­y­sis was under­tak­en on an inten­tion-to-treat (ITT) basis which includ­ed all ­patients known to have taken at least one dose of the drug and to have pro­vid­ed key data on at least one occa­sion after base­line. For each of the CLAU-S dimen­sions the two ­groups were com­pared in ­respect to dif­fer­ence ­between the ­initial and final val­ues.
­Results. Two hun­dred and twen­ty ­patients (108 naf­ti­drof­u­ryl, 112 pla­ce­bo) were eli­gible for the ITT anal­y­sis. Sig­nif­i­cant improve­ments, in ­favour of the ­active med­i­ca­tion, were seen for the dimen­sions ‘Daily ­living’, ‘Pain’ and ‘Social life’ (all p<0.01). For the dimen­sions com­plaints, dis­ease spe­cif­ic fears and mood, there were no sig­nif­i­cant dif­fer­enc­es ­between naf­ti­drof­u­ryl and pla­ce­bo. A mul­ti­var­i­ate anal­y­sis of covar­i­ance, which took into ­account such fac­tors as ­initial score, age and sex con­firmed the glo­bal super­ior­ity of naf­ti­drof­u­ryl (p=0.047).
Con­clu­sions. In this pla­ce­bo con­trolled study, using a dis­ease spe­cif­ic ques­tion­naire, naf­ti­drof­u­ryl has been shown to sig­nif­i­cant­ly ­improve sev­er­al ­aspects of the qual­ity of life of ­patients with IC.

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